This role will be located in Bellevue and is hybrid with a minimum of 3 days per week onsite.
What You'll Do- Serve as a strategic manager for the company's downstream process development and production operations to drive program timelines.
- Direct the strategic planning of downstream process development and manufacturing in support of all phases of clinical development including support of late clinical phase filings.
- Collaborate within cross-functional teams (Research, Development, Clinical, Quality, Regulatory), to define and execute development strategies for novel biotherapeutics and ADCs.
- Lead project-specific efforts in process development, scale-up, production and tech transfer of processes within and between CMOs.
- Participate in the development of RFP's to solicit project specific bids from CMOs/CROs.
- Develop SOWs defining work to be performed and provide subsequent oversight of experiments and activities conducted at the CMO/CRO.
- Develop highly productive manufacturing processes in a timely manner for novel antibody, multispecific and ADC therapeutics. Brings issues to the attention of appropriate personnel as necessary.
- Design, manage and support process characterization studies and develops control strategies for process validation.
- Author technical documents and deliver presentations to technical and project groups.
- Contribute to the preparation and submission of CMC portions of regulatory submissions and updates (IND and BLA).
- Work directly with Research and Development, Analytic Sciences, and Technology and Quality teams to plan and implement execution of downstream process development and manufacturing operations.
- Ensure that all developed processes are compatible with quality requirements including regulations, policies, applicable guidelines and procedures.
- Serve as primary point of contact with contract manufacturing organizations (CMOs) and performs person-in-plant duties as needed to provide technical support for ongoing manufacturing.
- Provide technical support for all CMC activities, including investigations, CAPAs, Change Controls, technology transfers, operation and lifecycle management of pre-clinical and cGMP manufacturing processes, ensuring all product delivery schedules are met.
- Author and review technical CMC documentation, including protocols, technical reports, manufacturing batch records, SOPs, change controls and deviations.
- Drive timely decisions and facilitate active communication and information flow between CMOs and Zymeworks team members.
- Foster strong, long-lasting cross-functional working relationships with internal and external CMC, Quality Assurance, Project Management, Clinical Operations, and external manufacturing entities to ensure successful development and manufacture of all products.
- Promote a culture of continuous improvement in product quality and productivity.
- Work closely with all internal and external resources to ensure DS supply availability.
What You'll Bring- University degree in science or engineering and a minimum of 8 years related experience in biopharmaceutical process development and GMP operations or an equivalent combination of education and experience.
- Experience working with contract manufacturing organizations.
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships.
- Excellent organizational skills and the ability to work effectively in a high paced, fast changing environment.
- Consistent analytical reasoning ability.
- Familiarity with QbD and Control Strategy Development or multivariate analysis and DoE approaches to process development a plus.
- Strong background in the regulatory compliance requirements for the cGMP production of biologicals for clinical and commercial use.
- Working knowledge of regulatory guidelines and expertise in CMC, PK or toxicology for the advancement of therapeutics through different phases of development.
- Proficiency with cGMP and ICH guidelines.
Total RewardsWe offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.
The base salary range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the location for which the job is posted and does not include bonus, equity, or benefits. Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate's location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).
Our total rewards package that includes:
- Industry leading vacation and paid time off
- Exceptional medical, dental and vision benefits by country
- Zymelife health and wellness benefits
- Matching RRSP / 401K / Pension program
- Employee Share Purchase Program
- Employee Equity Program
- Paid time off to volunteer in your community
This role is not eligible for relocation or immigration support.
The pay range for this role is:
146,250 - 224,250 USD per year (US)
